PMID- 24657236
OWN - NLM
STAT- MEDLINE
DCOM- 20150330
LR  - 20220316
IS  - 1522-9629 (Electronic)
IS  - 1094-5539 (Linking)
VI  - 28
IP  - 2
DP  - 2014 Aug
TI  - Omalizumab in patients with allergic (IgE-mediated) asthma and IgE/bodyweight 
      combinations above those in the initially approved dosing table.
PG  - 149-53
LID - S1094-5539(14)00035-2 [pii]
LID - 10.1016/j.pupt.2014.03.003 [doi]
AB  - BACKGROUND: When first approved in the European Union (EU), the omalizumab dosing 
      table had upper bodyweight and IgE limits of 150 kg and 700 IU/mL, respectively. 
      In this study, we assessed the safety, pharmacokinetics (PK) and pharmacodynamics 
      (PD) of omalizumab in patients with IgE/bodyweight combinations above those in 
      the original dosing table. METHODS: A multicentre, open-label, parallel-group 
      study assessed the safety, PK and PD of omalizumab in 32 patients with 
      mild-to-moderate allergic (IgE-mediated) asthma. Patients received two 
      subcutaneous injections of omalizumab at one of three dosage levels (450, 525, or 
      600 mg), chosen according to baseline IgE (300-2000 IU/mL) and bodyweight 
      (40-150 kg), with a 14-day interval between injections. RESULTS: Overall, 69 
      adverse events (AEs), none of them serious, were reported by 26 (81.3%) patients. 
      Analysis of laboratory measurements, vital signs and ECG data revealed no adverse 
      findings of clinical relevance. The PK profile was consistent with previous data 
      for lower doses. Mean maximum decrease of free IgE from screening was >/=99% for 
      all three doses, and mean free IgE concentrations remained <25 ng/mL for at least 
      2 weeks after the second dose. The reductions in free IgE were consistent with 
      levels previously associated with clinical improvements. CONCLUSIONS: The safety 
      and PK/PD findings from this study are consistent with previous data, and 
      supported the extension of the omalizumab dosing table to include those patients 
      with higher IgE/bodyweight combinations. Clinical trial registry and registration 
      number: clinicaltrials.gov (NCT00546143).
CI  - Copyright (c) 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Kornmann, Oliver
AU  - Kornmann O
AD  - Pulmonary Department, Internal Medicine, University Hospital Mainz, 
      Langenbeckstrasse 1, 55131 Mainz, Germany. Electronic address: 
      kornmann@ikf-pneumologie.de.
FAU - Watz, Henrik
AU  - Watz H
AD  - Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research 
      Center North, Member of the German Center for Lung Research, Grosshansdorf, 
      Germany. Electronic address: H.Watz@pulmoresearch.de.
FAU - Fuhr, Rainard
AU  - Fuhr R
AD  - PAREXEL International GmbH, Klinikum Westend, Haus 17, D-14050 Berlin, Germany. 
      Electronic address: Rainard.Fuhr@parexel.com.
FAU - Krug, Norbert
AU  - Krug N
AD  - Fraunhofer Institut fur Toxikologie und Experimentelle Medizin, 
      Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany. Electronic address: 
      norbert.krug@item.fraunhofer.de.
FAU - Erpenbeck, Veit J
AU  - Erpenbeck VJ
AD  - Novartis Pharma AG, Basel, Switzerland. Electronic address: 
      veit.erpenbeck@novartis.com.
FAU - Kaiser, Guenther
AU  - Kaiser G
AD  - Novartis Pharma AG, Basel, Switzerland. Electronic address: 
      guenther.kaiser@novartis.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT00546143
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140318
PL  - England
TA  - Pulm Pharmacol Ther
JT  - Pulmonary pharmacology & therapeutics
JID - 9715279
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Asthmatic Agents/*administration & dosage/adverse effects/pharmacokinetics
MH  - Antibodies, Anti-Idiotypic/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Asthma/*drug therapy/immunology
MH  - Body Weight
MH  - Dose-Response Relationship, Drug
MH  - Humans
MH  - Immunoglobulin E/*immunology
MH  - Middle Aged
MH  - Omalizumab
MH  - Patient Selection
MH  - Young Adult
OTO - NOTNLM
OT  - Bodyweight
OT  - IgE
OT  - Omalizumab
OT  - PK/PD
EDAT- 2014/03/25 06:00
MHDA- 2015/03/31 06:00
CRDT- 2014/03/25 06:00
PHST- 2013/11/08 00:00 [received]
PHST- 2014/03/06 00:00 [revised]
PHST- 2014/03/10 00:00 [accepted]
PHST- 2014/03/25 06:00 [entrez]
PHST- 2014/03/25 06:00 [pubmed]
PHST- 2015/03/31 06:00 [medline]
AID - S1094-5539(14)00035-2 [pii]
AID - 10.1016/j.pupt.2014.03.003 [doi]
PST - ppublish
SO  - Pulm Pharmacol Ther. 2014 Aug;28(2):149-53. doi: 10.1016/j.pupt.2014.03.003. Epub 
      2014 Mar 18.